Replacing the native mitral valve with the ReValve System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial tests the ReValve System as a surgical replacement for the native mitral valve in adults with symptomatic, clinically significant mitral regurgitation. Eligible participants must have at least moderate-to-severe MR (≥3+), recent qualifying transthoracic and transesophageal echocardiograms, NYHA class II–III or ambulatory IV status, LVEF ≥30%, and LVESD ≤65 mm. The procedure involves surgical implantation of the ReValve device at participating centers in Tbilisi, Georgia, with scheduled follow-up to monitor device safety and early clinical outcomes. The sponsor is ReValve Solutions Inc.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Symptomatic MR (≥3+) due to ischemic and non-ischemic cardiomyopathy etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 90 days prior to subject registration, with MR severity based principally on the TTE study.
* New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
* Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI)).
* Age greater than 18 years
* Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject consent.

Key Exclusion Criteria:

* Untreated clinically significant coronary artery disease requiring revascularization.
* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
* Status 1 heart transplant or prior orthotopic heart transplantation
* Cerebrovascular accident within 30 days prior to subject's consent
* Pregnant or planning pregnancy within next 12 months.
* Currently participating in an investigational drug or another device study.
* Evidence of LV or left atrium (LA) thrombus, vegetation or mass
* Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.

Where it's running

• Healthycore
  Tbilisi, Georgia Recruiting
• Tbilisi Heart and Vascular Center
  Tbilisi, Georgia Recruiting
• Tiblisi Heart Center
  Tbilisi, Georgia Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.